FDA 510(k)

GCI Sterilization Wrappers

K号: K250321 · 2025-06-06

决定日期2025-06-06

产品代码FRG

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

GCI Sterilization Wrappers is the device name listed in this FDA 510(k) record. The listed applicant is George Courey, Inc.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K250321. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GCI Sterilization Wrappers?

GCI Sterilization Wrappers is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is George Courey, Inc.. The 510(k) number is K250321.

When did GCI Sterilization Wrappers receive FDA 510(k) clearance?

GCI Sterilization Wrappers received FDA 510(k) clearance on 2025-06-06, under 510(k) number K250321.

Who is the listed applicant for GCI Sterilization Wrappers?

The FDA 510(k) record lists George Courey, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GCI Sterilization Wrappers?

The FDA product code for GCI Sterilization Wrappers is FRG.

列明George Courey, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233571GCI Surgical Gown

相关器械（代码：FRG）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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